Method for treating a prosthesis having an apertured structure and associated devices

ABSTRACT

A prosthesis having an apertured structure is located in a chamber ( 11 ) which is taken to sub-atmospheric pressure. Once sub-atmospheric pressure has been reached, a liquid, optionally containing pharmacological agents, is introduced into the chamber. Drawn by the sub-atmospheric pressure, the liquid saturates the apertured structure of the prosthesis. In this way, the invention eliminates the risk of air being trapped in the apertured structure that could give rise to the formation of blood clots after implantation of the prosthesis. The liquid can contain drugs that penetrate the prosthesis, performing their therapeutic action locally and over time after implantation.

FIELD OF THE INVENTION

[0001] The present invention generally relates to a method for treatingprostheses having an apertured structure. In particular, this inventionrelates to a method and a device for saturating a prosthesis with aliquid.

BACKGROUND OF THE INVENTION

[0002] The term “apertured structure” refers to those prostheses (suchas, for example, so-called vascular grafts or the suture rings ofcardiac valve prostheses) comprising, entirely or in part, from tissuestructures, spongy masses and/or having elaborate geometries with slits,cavities and spaces, i.e., apertures. In use, such prostheses tend tohold air inside them with a consequent risk of the formation of bloodclots in the period following implantation, due to the presence of airbubbles contained or otherwise held by the prosthesis. The simplesolution, sometimes adopted during the implantation operation, ofimmersing the prosthesis in, for example, a physiological saline bath,does not satisfactorily solve the problem, both because the results candepend, possibly significantly, on the time dedicated to this treatmentand the ability of the person conducting it, and because it is in anycase difficult to remove all the air from the prosthesis.

SUMMARY OF THE INVENTION

[0003] The present invention therefore aims to eliminate in a radicalmanner the risk of the occurrence of these negative phenomena. Theinvention also concerns devices which can be used in the performance ofthis method. An important advantage of the invention is that the liquidsuch as, for example, physiological saline that is introduced into thepores, even the deep pores, to replace the air that is naturallypresent, can be supplemented with drugs such as, for example,antibiotics, anti-thrombotic drugs, drugs that promote the integrationbetween the prosthesis and the surrounding biological tissues, or growthfactors. Because the liquid is held in the pores, the drug or drugs canexert their action locally and extended over time. It is noted that theword “drug”, as used herein, also includes the possible use of a bindingagent applied to the prosthesis in order to attract thereto, with abinder-ligand association mechanism, pharmacologically active agentsintroduced into the patient's body.

[0004] In one aspect, this invention is a method for the treatment of aprosthesis having an apertured structure, comprising placing aprosthesis having an apertured structure into a holding chamber;producing sub-atmospheric pressure in the holding chamber; andintroducing a liquid into the holding chamber to saturate theprosthesis. The sub-atmospheric pressure is selected so that after theintroduction of the liquid into the holding chamber, the prosthesis issubstantially free of air. The liquid may be substantially inert, e.g.,physiological saline, or may comprise a drug. Sub-atmospheric pressureis established by connecting the holding chamber to a vacuum line, andliquid is introduced into the holding chamber by connecting the holdingchamber to a liquid supply line, the liquid supply line being providedwith a cut-off element The sub-atmospheric pressure of the holdingchamber reaches approximately −850 mbar. Preferably, the holding chamberis connected to the vacuum line for less than about 60 seconds and theliquid flows into the chamber for less than about 60 seconds.

[0005] In a second aspect, this invention is a device for the treatmentof a prosthesis having an apertured structure comprising a casingdefining a holding chamber for a prosthesis, the casing including anopening for the introduction of the prosthesis into the chamber and asealing element disposed around the opening to allow a sub-atmosphericpressure to be drawn within the casing; a first fluid line leading tothe casing for connecting the chamber to a source of sub-atmosphericpressure; a second fluid line for connecting the chamber to a source ofliquid; and a valve acting on the first and second fluid lines toconnect the chamber in succession with the source of sub-atmosphericpressure and the source of liquid. The source of liquid preferably is acontainer and a vacuum pump provides a source of sub-atmosphericpressure. Preferably, a safety cut-off element is interposed in thesecond fluid line, selectively activatable to open or close the secondfluid line. Also, in a preferred embodiment, a filtration elementcomprising a sterile, fluid-permeable barrier is interposed in the firstfluid line. A casing carrying a connector defines a common part of thefirst and second fluid lines. The connector may be a luer connector. Thecasing may have two complementary parts connectable together with theinterposition of a sealing element; the two complementary parts may besealingly connected together by locking means.

[0006] In a third aspect, this invention is a kit for the treatment of aprosthesis having an apertured structure, comprising a casing defining aholding chamber for a prosthesis, the casing including an opening forthe introduction of the prosthesis into the chamber and a sealingelement disposed around the opening to permit sub-atmospheric pressureto be drawn within the casing; a first fluid line leading to the casingfor connecting the chamber to a source of sub-atmospheric pressure; asecond fluid line for connecting the chamber to a source of liquid; anda valve acting on the first and second fluid lines to connect thechamber in succession with the source of sub-atmospheric pressure andthe source of liquid, wherein the casing, the first fluid line, thesecond fluid line, and the valve are packaged in a sterile envelope.

[0007] In a fourth aspect, this invention is a container for aprosthesis having an apertured structure used to saturate the prosthesiswith a liquid, the container comprising a casing defining a holdingchamber for the prosthesis; at least one connector associated with thecasing and configured to enable the connection of the prosthesis holdingchamber to a source of sub-atmospheric pressure, the casing beingsealably closable and having a structure that retains the substantialintegrity of the prosthesis in the presence of sub-atmospheric pressurewithin the prosthesis holding chamber, and a liquid reservoir connectedto the prosthesis holding chamber, such that the liquid from thereservoir saturates the apertured structure of the prosthesis as aresult of the liquid being drawn into the holding chamber due to thesub-atmospheric pressure. The connector may be either a luer connectoror a perforable membrane. Alternatively, the connector may be a luerconnector integral with a perforable membrane.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The invention will now be described, purely by way ofnon-limiting examples, with reference to the accompanying drawings, inwhich:

[0009]FIG. 1 shows a perspective view of a system for performing themethod according to the invention.

[0010]FIG. 2 illustrates in greater detail the structure of one of theparts shown in FIG. 1.

[0011]FIG. 3 illustrates a container for a prosthesis suitable for usein the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] Before proceeding to the description of FIG. 1, attention shouldbe drawn to FIG. 3. This drawing illustrates a container that can beused for the sterile packaging of a prosthesis such as a cardiac valveprosthesis. With the exception of the presence of some characteristicelements (which will be referred to specifically below) relating to theapplication of the invention, the container illustrated in FIG. 3corresponds to the container currently utilised by Sorin BiomedicaCardio S.p.A, Saluggia, Italy, for cardiac valve prostheses sold bySorin Biomedica Cardio S.p.A. under the commercial name Bicarbon™. Thiscontainer includes an outer shell formed from two cup-shape half shells1 and 2 made from plastic material sealed (according to known criteria)along their respective mouth edges to define an inner chamber in which afurther container 3 is located. Container 3 comprises cup-like body 4within which the valve prosthesis V is located. Body 4 is closed alongits mouth part by sealing disc 5. Sealing disc 5 is usually formed froma material able to form a sterile, although fluid-permeable, barrier.For example, it can be the material sold by DuPont, of Wilmington, Del.under the commercial name Tyvek®.

[0013] With the exception of the innovative elements referred to above,which will be described better below, the container of FIG. 3 ismanufactured according to criteria that are widely known to one skilledin the art. This makes the description of further details superfluous asthey are not in themselves necessary in order to understand and put intoeffect the invention.

[0014] Of course, the above also applies to the valve prosthesis V. Inthis case, it is sufficient to note that the valve prosthesis itself hasa suture ring R of textile material, possibly with a spongy core, alongits outer edge. In other words, it is a prosthesis having, at least inpart, an “apertured” structure in the sense of the meaning describedabove.

[0015] The device illustrated in FIG. 1, generally indicated 10,includes a vacuum bell 11 as its main element. Vacuum bell 11 comprisesa casing that is sealably closed or closable so that it can be taken toa desired level of sub-atmospheric pressure (i.e., to a “vacuum”).

[0016] In the embodiment illustrated here (which is such that, as willbe seen better below, the function of vacuum bell 11 can also beperformed, for example, by the prosthesis container), bell 11 has thestructure illustrated in greater detail in FIG. 2, being formed fromcup-like holding body 12 with associated closure cover 13. Holding body12 and cover 13 separate to form an opening. The dimensions and shape ofcup-like body 12 are chosen so as to enable the prosthesis to beintroduced into bell 11. In the embodiment illustrated here, the shapeand dimensions of bell 11 are such that it can accommodate sterilecontainer 3 holding the prosthesis, such as is shown in FIG. 3.

[0017] Both cup-like body 12 and cover 13 can be formed, for example,from a material such as a metal material or, even better, at least asregards cover 13, from a transparent plastic material such aspolycarbonate or polymethacrylate so that it is possible to observe theinner chamber of bell 11 from the outside during the treatment whichwill be described below.

[0018] The method according to the invention is preferably performed inthe operating theater, therefore in a sterile environment or closethereto. Consequently, the choice of materials forming the various partsof device 10 must take account of this preference and be sterilisable.Cover 13 comprises sealing element 14 disposed along its outer edge. Thesealing element typically is a sealing gasket or ring (such as anO-ring). Cover 12 is traversed by radial duct 15 leading to one or moreapertures opening into the upper part of the inner volume of bell 11when cover 13 is fitted to body 12. Duct 15 leads to its outer end withrespect to cover 13, and therefore to bell 11, at connector 16 (forexample, of the type currently known as a “luer” connection) projectingoutward from bell 11.

[0019] However, it is clear that the relative positioning of the partsdescribed above is not in any way essential. For example, a sealing ringcould be located on the mouth part of the cup-like body. The duct orducts could have different paths and/or be provided on the cup-likebody, or partly on the cup-like body and partly on the cover. Lockingmeans such as clamp 17 enables bell 11 to be positioned and cover 13 tobe held sealably closed on the mouth part of cup-like body 12 during thetreatment of the prosthesis. In the embodiment illustrated here, clamp17 includes base 18 defining a support surface for bell 11, pillar 19extending vertically from the base 18, and an upper part 20 projectingover bell 11 positioned on base 18. Upper part 20 comprises toggle clampelement 21 of the type currently known as a Destaco clamp, leading topressure foot 22.

[0020] The method for positioning bell 11 in clamp 17 is clear from acomparison of FIG. 2 in which bell 11 is illustrated in an openposition, with FIG. 1 in which bell 11, into which it is assumed thatcontainer 3 containing the prosthesis V has already been introduced, hasbeen positioned in clamp 17. Toggle clamp 21 is then operated so thatfoot 22 presses cover 13 firmly against the mouth edge of cup-like body12.

[0021] Container, reservoir, or bag 23 is a source of liquid and islocated on associated pillar or support 30. Bag 23 contains apredetermined volume (for example, 200 cubic centimeters) of a liquidintended to be utilised for impregnating the apertured parts of theprosthesis V according to the methods that will be better illustratedbelow. Preferably container or bag 23 is sterile. The liquid in questionmay be an inert liquid such as physiological saline, or an active liquidcomprising one or more drugs. These drugs can also be added to the inertliquid in bag or container 23 through a suitable gate or opening using atechnique well known in medical practice.

[0022] Valve 24 (such as a T-valve or other equivalent fluid handlingcomponent) is mounted on or otherwise connected to connector 16. Valve24 permits the communication of connector 16 and thus duct 15 with fluidand vacuum lines. That is, as can be seen in FIG. 1, connector 16communicates with vacuum line or first fluid line 26 that connects valve24 to a source of sub-atmospheric pressure 27 (typically a vacuum pumpor a vacuum line available wherever the treatment is effected, forexample, in the operating theater). Connector 16 also communicates withsecond fluid line 25 that connects valve 24 to bag 23.

[0023] Fluid lines 25 and 26 can be formed, for example, from flexibletubing made from soft polyvinylchloride with an internal diameter of,for example, approximately 1 mm and an outer diameter of, for example,approximately 3.5 mm. Preferably, a cut-off element is interposed influid line 25, usually close to valve 24, which is able to interruptline 25 if necessary. For example, safety cut-off switch or clamp 28 isshown interposed in line 25 to interrupt the flow of fluid from bag 23.

[0024] Filter 260 can be interposed at any point along the line 26between the bell 11 and the source of sub-atmospheric pressure 27. Thefilter provides a sterile, fluid-permeable barrier. In the testsconducted by Sorin Biomedica Cardio S.p.A., a Leybold Trivac AF1.6vacuum pump was used as the source of sub-atmospheric pressure.

[0025] With the possible application of the invention being directedtowards the surgical field, this being preferable in many ways, thevarious parts of device 10 and, in particular, parts 12 and 13 of vacuumbell 11, together with the associated accessories (sealing gasket 14,bag 23, fluid lines 25 and 26, valve 24, etc.), preferably are formedfrom materials able to ensure the use of the method in a sterileenvironment. This therefore means that components are preferably formedas single use components and/or components that are sterilisable using,for example, ethylene oxide.

[0026] Preferably, the system for generating and applying thesub-atmospheric pressure (bell 11, pump 27 and associated connections,in the embodiment illustrated here) are chosen and dimensioned so as toensure that a typical level of sub-atmospheric pressure of approximately−850 mbar is reached in the inner chamber of bell 11. Usually, system 10is completed by a bath (not shown in the drawings) for collecting liquidfrom bag 23 that may be released on opening bell 11.

[0027] Preferably, the assembly formed by vacuum bell 11, valve 24,fluid lines 25 and 26, and, possibly, bag 23 is configured to bepackaged in a sterile envelope, i.e., in the form of a kit. Thisarrangement enables the system to be used directly in the operatingtheater, and therefore at the time of implanting a prosthesis, such asthe valve prosthesis V, in the following sequence of operations:

[0028] removing the equipment described above and connecting it viafirst fluid line 26 to the source of sub-atmospheric pressure 27,

[0029] opening the outer container of the prosthesis by unrolling anadhesive strip (not shown) that connects the mouth parts of thehalf-shells 1 and 2 (it is recalled that the present descriptionsupposes that the prosthesis container corresponds to that illustratedin FIG. 3 without the further elements that will be described below),

[0030] positioning inner container 3, in which the prosthesis V islocated, into cup-like body 12 of bell 11,

[0031] closing bell 11 with cover 13 and positioning bell 11 in clamp 17which is then locked by acting on closure device 21,

[0032] starting vacuum pump 27 (or, in any case, activating line 26 asthe source of sub-atmospheric pressure),

[0033] on reaching the required level of sub-atmospheric pressure (inthe case of the level of −850 mbar and the kind of pump 27 referred toabove, this result can be achieved quickly, typically, in less thanabout 60 seconds), switching valve 24 to the position that transfersconnector 16, and thus duct 15, previously connected to line 26, to line25, before opening safety clamp 28, if present. At this point, theliquid in bag 23 flows into the inner chamber of bell 11, penetratingthe inside of container 3 (across seal 5 which is, as earlier noted,permeable). In this way, the liquid, possibly containing one or moredrugs, completely saturates ring R, that is, the apertured part of theprosthesis, definitively preventing any air bubbles from being heldtherein or being able to enter it If the liquid contains drugs, thedrugs become trapped in the pores of the apertured part of theprosthesis and, consequently, can perform their pharmacological actionlocally over time following implantation;

[0034] deactivating vacuum pump 27 and, in any case, disconnecting valve24 from the source of sub-atmospheric pressure;

[0035] completing the filling of the inner volume of bell 11 (which, inthe conditions described above, can occur in a short period of time,this also being typically less than about 60 seconds) with the possibleclosure of safety clamp 28 and turning valve 24 to an emptying position;

[0036] opening clamp 17, with the consequent release therefrom of bell11 which is opened to gain access to container 3; and

[0037] releasing and opening container 3 by removing sealing layer 5 andextracting the prosthesis V, now ready for use.

[0038] Tests conducted by Sorin Biomedica Cardio S.p.A. show that thisseries of operations can be effected rapidly in surgery in not more thanthree minutes, including the time necessary to prepare device 10. Inpractice, the treatment described above, which leads to the completeremoval of bubbles from the prosthesis (and its possible impregnationwith drugs), can easily be achieved in a short time interval, thusmaking it completely compatible with the normal operation times.

[0039] The arrangement according to the invention is thus based on theprinciple of locating the prosthesis to be treated in a treatmentchamber which is then taken to a level of sub-atmospheric pressure. Thischamber is then connected to a liquid supply source (bag 23, in theembodiment illustrated) via a liquid supply line. Drawn by thesub-atmospheric pressure in the chamber (and possibly driven by anexternal over-pressurisation applied using known means, not specificallyillustrated in the drawings: for example, squeezing bag 23, evenmanually can be sufficient), the liquid completely saturates theapertured parts of the prosthesis, preventing any air bubbles remainingor becoming trapped in the apertures. The liquid can be inert (such as,for example, physiological saline) or it can be a vehicle for activeprincipals such as, for example, drugs. In this way, it is possible toobtain the additional result of saturating the apertured parts of theprosthesis with pharmacologically active principals that can be releasedgradually at the implantation site, effecting a local action over time.All of this has the further advantage that the nature and quantity ofdrug can be from time to time selected by the surgeon or surgeonsdepending on the specific implantation requirements, and this decisioncan be taken just moments before proceeding to implant the prosthesis.

[0040] The practical effectiveness of the arrangement described abovehas been tested by producing a device that enables the detection of anyresidual air trapped within the tissue meshes of the suture rings ofvalve prostheses currently produced by Sorin Biomedica Cardio S.p.A. Thetest device (not specifically illustrated in the drawings) enables avacuum level to be achieved that corresponds to a pressure of not lessthan −20 mbar (therefore, a level close to the surface tension of water)on to beakers containing two suture rings immersed in an aqueoussolution, the first treated using the method described above and thesecond comparison ring saturated with water for simple immersion. Thisis in order to extract any air present in the mesh of the two suturerings.

[0041] In practice, the test device was formed with a vacuum pumpconnected to a vacuum bell having an observation window. This circuitwas subjected to the action of a Jofra LPCA hand-operated vacuumcalibrator in order to bring the pressure to a level not less than −20mbar. Two beakers full of a previously de-gassed aqueous solution wereintroduced into the bell. The two suture rings (one treated according tothe invention, and the other as a comparison) described above wereimmersed in these beakers. The behavior was recorded by video recorderthrough the observation window in the bell.

[0042] Three successive tests were performed. In all three, no escape ofresidual air was detected in the suture rings treated according to theinvention and, therefore, no residual air was present. On the otherhand, the escape, and therefore the presence, of air was clearlydetected in the untreated rings.

[0043] Device 10 shown in FIG. 1 corresponds to just one of the manypossible embodiments of the invention and, the basic principle of theinvention remaining the same, the arrangement described lends itself tomany variations, some of which are particularly significant. Forexample, even without substantially modifying the structure of thedevice shown in FIG. 1, cup-like holding body 12 can be integrated intothe structure of clamp 17, or pillar 30 that supports bag 23 can beintegrated into the structure of clamp 17. In a complementary manner,vacuum bell 11 can itself be formed so as firmly to seal the vacuumwithout using an external structure such as clamp 17. Such an example ofthis is a container for keeping grocery products sealed, for example, ofthe type currently known as an albarello seal.

[0044] In addition, it is possible to envision the use of the containerwhich holds the prosthesis as the vacuum bell. For example, withreference to FIG. 3, half-shell 1 can have a connector such as connector16 (the use of the same reference numeral as utilised in FIG. 1 isintended to show this possible correspondence) with the possiblemodification of the mechanism for coupling two half-shells 1 and 2, forexample, using a sealing ring such as an O-ring. This is so as to beable to utilise directly the casing defined by the half-shells 1 and 2sealingly coupled together as a vacuum bell. To this end, connector 16is configured so as to enable the connection to a source ofsub-atmospheric pressure (for example, pump 27 via fluid line 26). Atthe same time, connector 16 is configured as a means for introducinginto the casing formed from half-shells 1 and 2 the liquid intended tosaturate the apertured structure of the prosthesis. That is, liquidwould be drawn into the casing because of the sub-atmospheric pressureinduced in the casing itself. This therefore means that the casing ofthe prosthesis container is directly connectable to a source ofsub-atmospheric pressure (pump 27) and a source of liquid (bag 23) inorder to effect the treatment described above without having to preparevacuum bell 11 for this purpose. To this end, the container (in thiscase, the casing defined by half-shells 1 and 2) must have a structurethat ensures the integrity of the prosthesis contained therein when thelevel of sub-atmospheric pressure (for example, −850 mbar) is reached.

[0045] Similarly, one or more arcuate slots, indicated 200, are usuallypresent in the lower half-shell 2 of the container shown in FIG. 3.These slots are normally closed by one or more sheets, for example, ofthe material known as Tyvek™ already mentioned above, which is able toact as a sterile, fluid-permeable barrier. Naturally, when theprosthesis container is to be utilised as the vacuum bell, these slotsmust be closed, for example, with one or more elements (for example,self adhesive) acting as a seal or sealing plug, as schematicallyindicated 201 in FIG. 3.

[0046] In particular, where it is integrated with a container, connector16 can be a different type and shape from the luer-type of connectionreferred to specifically in FIG. 3. It can, for example, utilise adifferent kind of luer connection (for example, a male connector inplace of a female connector, or vice versa). Connector 16 could also bein communication with a liquid introduction means such as a perforablemembrane which can be pierced with a needle, the axial lumen of whichleads to valve 24. As is known, a luer connector also can be integralwith a perforable membrane. That is, a luer-type connector and aperforable membrane could be used either to connect to the liquid sourceand/or to the vacuum source.

[0047] The choice of one of these arrangements, or alternativeconnection arrangements that are well known to one skilled in the art,is clearly correlated to the nature of the container utilised as thevacuum bell and/or the requirement of ensuring the necessary conditionsof sterility of the connector before use.

[0048] An arrangement can also be proposed in which the vacuum bell(whether separate or constituted by the prosthesis container) includes atank for the filling liquid, thus avoiding the necessity of having touse an external reservoir or container such as bag 23 and the connectionline (indicated 25 in FIG. 1), and the associated elements.

[0049] It is equally clear that the reference to a cardiac valveprosthesis provided with a suture ring, as an apertured part, is purelyby way of example. The arrangement according to the invention in factlends itself to be utilised with any prosthesis including at least onepart apertured in the terms referred to in the introduction to thepresent description. It can therefore be any kind of prosthesis (to givean example, a vascular prosthesis, including a prosthesis made frommicroporous material such as a vascular prostheses made from expandedpolytetrafluoroethylene (PTFE)) which can be introduced directly intovacuum chamber 11 or located in this treatment chamber when theprosthesis itself is still in an associated sterile container, such asinner container 3 of FIG. 3, with the requirement of ensuring theaccessibility of the apertured part of the prosthesis by the treatmentliquid remaining, of course, the same.

[0050] It follows therefore that, the principle of the inventionremaining the same, the details of construction and the embodiments canbe widely varied with respect to that described and illustrated, withoutdeparting from the ambit of the present invention.

What is claimed is:
 1. A method for the treatment of a prosthesis havingan apertured structure, comprising: placing a prosthesis having anapertured structure into a holding chamber; producing sub-atmosphericpressure in the holding chamber; and introducing a liquid into theholding chamber to saturate the prosthesis.
 2. A method according toclaim 1, wherein the sub-atmospheric pressure is selected so that afterthe introduction of the liquid into the holding chamber, the prosthesisis substantially free of air.
 3. A method according to claim 1, whereinthe liquid is substantially inert.
 4. A method according to claim 3,wherein the liquid is physiological saline.
 5. A method according toclaim 1, wherein the liquid comprises a drug.
 6. A method according toclaim 1, wherein the step of producing sub-atmospheric pressurecomprises connecting the holding chamber to a vacuum line; and the stepof introducing a liquid into the holding chamber comprises connectingthe holding chamber to a liquid supply line, the liquid supply linebeing provided with a cut-off element.
 7. A method according to claim 1,wherein the sub-atmospheric pressure of the holding chamber isapproximately −850 mbar.
 8. A method according to claim 6, wherein theholding chamber is connected to the vacuum line for less than about 60seconds.
 9. A method according to claim 1, wherein the liquid flows intothe chamber for less than about 60 seconds.
 10. A device for thetreatment of a prosthesis having an apertured structure comprising: acasing defining a holding chamber for a prosthesis, the casing includingan opening sized to allow for the introduction of the prosthesis intothe chamber and a sealing element disposed around the opening to allow asub-atmospheric pressure to be drawn within the casing; a first fluidline leading to the casing for connecting the chamber to a source ofsub-atmospheric pressure; a second fluid line for connecting the chamberto a source of liquid; and a valve acting on the first and second fluidline to connect the chamber in succession with the source ofsub-atmospheric pressure and the source of liquid.
 11. A deviceaccording to claim 10, wherein the source of liquid is a container. 12.A device according to claim 11, wherein the liquid is a substantiallyinert liquid.
 13. A device according to claim 12, wherein the liquid isphysiological saline.
 14. A device according to claim 11, wherein theliquid comprises a drug.
 15. A device according to claim 10, furthercomprising a vacuum pump as a source of sub-atmospheric pressure.
 16. Adevice according to claim 10, wherein a safety cutoff element isinterposed in the second fluid line, selectively activatable to open orclose the second fluid line.
 17. A device according to claim 10, whereina filtration element comprising a sterile, fluid-permeable barrier isinterposed in the first fluid line.
 18. A device according to claim 10,wherein the casing carries a connector defining a common part of thefirst and said second fluid lines.
 19. A device according to claim 18,wherein the connector is a luer connector.
 20. A device according toclaim 10, wherein the casing has two complementary parts connectabletogether with the interposition of a sealing element.
 21. A deviceaccording to claim 20, wherein the two complementary parts of the casingare sealingly connected together by locking means.
 22. A kit for thetreatment of a prosthesis having an apertured structure, comprising: acasing defining a holding chamber for a prosthesis, the casing includingan opening sized to allow for the introduction of the prosthesis intothe chamber and a sealing element disposed around the opening to permitsub-atmospheric pressure to be drawn within the casing; a first fluidline leading to the casing for connecting the chamber to a source ofsub-atmospheric pressure; a second fluid line for connecting the chamberto a source of liquid; and a valve acting on the first and second fluidlines to connect the chamber in succession with the source ofsub-atmospheric pressure and the source of liquid, wherein the casing,the first fluid line, the second fluid line, and the valve are packagedin a sterile envelope.
 23. A container for a prosthesis having anapertured structure used to saturate the prosthesis with a liquid, thecontainer comprising: a casing defining a holding chamber for theprosthesis; at least one connector associated with the casing andconfigured to enable the connection of the prosthesis holding chamber toa source of sub-atmospheric pressure, the casing being sealably closableand having a structure that retains the substantial integrity of theprosthesis in the presence of sub-atmospheric pressure within theprosthesis holding chamber, and a liquid reservoir connected to theprosthesis holding chamber, such that the liquid from the reservoirsaturates the apertured structure of the prosthesis as a result of theliquid being drawn into the holding chamber due to the sub-atmosphericpressure.
 24. A container according to claim 23, wherein the connectoris one of a luer connector or a perforable membrane.
 25. A containeraccording to claim 23, wherein the connector is a luer connectorintegral with a perforable membrane.